Systems and methods for the fixation or fusion of bone using compressive implants

ABSTRACT

First and second bone segments separated by a fracture line or joint can be fixated or fused by creating an insertion path through the first bone segment, through the fracture line or joint, and into the second bone segment. An anchor body is introduced through the insertion path. The distal end of the anchor body is anchored in the interior region of the second bone segment. An elongated implant structure is passed over the anchor body to span the fracture line or joint between the bone segments. The proximal end of the anchor body is anchored to an exterior region of the first bone segment to place, in concert with the anchored distal end, the anchor body in compression, to thereby compress and fixate the bone segments relative to the fracture line or joint.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/786,037, filed Mar. 5, 2013, titled “SYSTEMS AND METHODS FOR THEFIXATION OR FUSION OF BONE USING COMPRESSIVE IMPLANTS,” U.S. PatentApplication Publication No. 2013-0184769-A1, now U.S. Pat. No.8,734,462, which is a continuation of U.S. patent application Ser. No.12/924,784, filed Oct. 5, 2010, titled “SYSTEMS AND METHODS FOR THEFIXATION OR FUSION OF BONE USING COMPRESSIVE IMPLANTS,” U.S. PatentApplication Publication No. 2011-0087296-A1, now U.S. Pat. No.8,388,667, which is a continuation-in-part of U.S. patent applicationSer. No. 11/136,141, filed May 24, 2005, titled “SYSTEMS AND METHODS FORTHE FIXATION OR FUSION OF BONE,” U.S. Patent Application Publication No.2006-0036322-A1, now U.S. Pat. No. 7,922,765 B2, which is acontinuation-in-part of U.S. patent application Ser. No. 10/914,629,filed Aug. 9, 2004, titled “SYSTEMS AND METHODS FOR THE FIXATION ORFUSION OF BONE,” U.S. Patent Application Publication No. 2006-003625-A1,now abandoned, each of which are herein incorporated by reference intheir entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

This application relates generally to the fixation or fusion of bone.

BACKGROUND

Many types of hardware are available both for the fixation of bones thatare fractured and for the fixation of bones that are to fused(arthrodesed).

For example, the human hip girdle (see FIGS. 9 and 10) is made up ofthree large bones joined by three relatively immobile joints. One of thebones is called the sacrum and it lies at the bottom of the lumbarspine, where it connects with the L5 vertebra. The other two bones arecommonly called “hip bones” and are technically referred to as the rightilium and the left ilium. The sacrum connects with both hip bones at thesacroiliac joint (in shorthand, the SI-Joint).

The SI-Joint functions in the transmission of forces from the spine tothe lower extremities, and vice-versa. The SI-Joint has been describedas a pain generator for up to 22% of lower back pain.

To relieve pain generated from the SI Joint, sacroiliac joint fusion istypically indicated as surgical treatment, e.g., for degenerativesacroiliitis, inflammatory sacroiliitis, iatrogenic instability of thesacroiliac joint, osteitis condensans ilii, or traumatic fracturedislocation of the pelvis. Currently, screw and screw with plates areused for sacro-iliac fusion. At the same time the cartilage has to beremoved from the “synovial joint” portion of the SI joint. This requiresa large incision to approach the damaged, subluxed, dislocated,fractured, or degenerative joint.

SUMMARY OF THE DISCLOSURE

The invention provides bone fixation/fusion systems, devices, andrelated methods for stabilizing adjacent bone segments in a minimallyinvasive manner. The adjacent bone segments can comprise parts of thesame bone that have been fractured, or two or more individual bonesseparated by a space or joint. As used herein, “bone segments” or“adjacent bone regions” refer to either situation, i.e., a fracture linein a single bone (which the devices serve to fixate), or a space orjoint between different bone segments (which the devices serve toarthrodese or fuse). The devices can therefore serve to perform afixation function between two or more individual bones, or a fusionfunction between two or more parts of the same bone, or both functions.

One aspect of the invention provides assemblies and associated methodsfor the fixation or fusion of bone structures comprising first andsecond bone segments separated by a fracture line or joint. Theassemblies and associated methods comprise an anchor body sized andconfigured to be introduced into the first and second bone segments. Theanchor body has a distal end located in an interior region of the secondbone segment; a proximal end located outside an exterior region of thefirst bone segment; and an intermediate region spanning the fractureline or joint between the first and second bone segments. The assembliesand associated methods also include a distal anchor secured to theinterior region of the second bone segment and affixed to the distal endof the anchor body to anchor the distal end in the second bone segment.The assemblies and associated methods further include a proximal anchorsecured to the exterior region of the first bone segment and affixed tothe proximal end of the anchor body, which, in concert with the distalanchor, places the anchor body in compression to compress and fixate thebone segments relative to the fracture line or joint. The assemblies andassociated methods also include an elongated implant structure carriedby the intermediate region of the anchor body and spanning the fractureline or joint between the bone segments. The elongated implant structureincludes an exterior surface region treated to provide bony in-growth orthrough-growth along the implant structure, to accelerate the fixationor fusion of the first and second bone segments held in compression andfixated by the anchor body.

The bone fixation/fusion systems, devices, and related methods are wellsuited for stabilizing adjacent bone segments in the SI-Joint.

Accordingly, another aspect of the invention provides a method for thefusion of the sacral-iliac joint between an iliac and a sacrum. Themethod comprises creating an insertion path through the ilium, throughthe sacral-iliac joint, and into the sacrum. The method includesproviding an anchor body sized and configured to be introduced throughthe insertion path laterally into the ilium and sacrum. The anchor bodyhas a distal end sized and configured to be located in an interiorregion of the sacrum; a proximal end sized and configured to be locatedoutside an exterior region of the iliac; and an intermediate regionsized and configured to span the sacral-iliac joint. The method includesproviding an elongated implant structure sized and configured to bepassed over the anchor body to span the sacral-iliac joint between theiliac and sacrum. The elongated implant structure includes an exteriorsurface region treated to provide bony in-growth or through-growth alongthe implant structure. The method includes introducing the anchor bodythrough the insertion path from the ilium, through the sacral-iliacjoint, and into the sacrum. The method includes anchoring the distal endof the anchor body in the interior region of the sacrum. The methodincludes passing the elongated implant structure over the anchor body tospan the sacral-iliac joint between the ilium and sacrum, and anchoringthe proximal end of the anchor body to an exterior region of the ilium,which, in concert with the anchored distal end, places the anchor bodyin compression to compress and fixate the sacral-iliac joint. The bonyin-growth or through-growth region of the implant structure acceleratesthe fixation or fusion of the sacral-iliac joint held in compression andfixated by the anchor body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side section view of a compression stem assembly assembledin adjacent bone regions, which are shown in FIG. 1 in adiagrammatically fashion for the purpose of illustration, withoutanatomic detail, which is later shown, e.g., in FIG. 16.

FIG. 2 is an exploded perspective view of the components of thecompression stem assembly shown in FIG. 1 prior to assembly.

FIGS. 3 to 7 are alternative embodiments of an implant structure whichforms a part of the compression stem assembly shown in FIGS. 1 and 2,illustrating different cross-sectional geometries and configurations forthe implant structure 20.

FIGS. 8A to 8L are side section views of the introduction and assemblyof the compression stem assembly shown in FIGS. 1 and 2, which is shownin FIGS. 8A to 8L in a diagrammatically fashion for the purpose ofillustration, without anatomic detail, as later shown, e.g., in FIG. 16.

FIGS. 9 and 10 are, respectively, anterior and posterior anatomic viewsof the human hip girdle comprising the sacrum and the hip bones (theright ilium, and the left ilium), the sacrum being connected with bothhip bones at the sacroiliac joint (in shorthand, the SI-Joint).

FIGS. 11 to 13A and 13B are anatomic views showing, respectively, inexploded perspective, assembled perspective, assembled anterior view,and assembled axial section view, the implantation of three implantstructures, without association of a compression stem assembly, for thefixation of the SI-Joint using a lateral approach laterally through theilium, the SI-Joint, and into the sacrum S1.

FIGS. 14 to 16A and 16B are anatomic views showing, respectively, inexploded perspective, assembled perspective, assembled anterior view,and assembled axial section view, the implantation of three implantstructures, in association with a compression stem assembly, for thefixation of the SI-Joint using a lateral approach laterally through theilium, the SI-Joint, and into the sacrum S1.

FIGS. 17 to 19A and 19B are anatomic views showing, respectively, inexploded perspective, assembled perspective, assembled lateral view, andassembled axial section view, the implantation of three implantstructures, without association of a compression stem assembly, for thefixation of the SI-Joint using a postero-lateral approach entering fromthe posterior iliac spine of the ilium, angling through the SI-Joint,and terminating in the sacral alae.

FIGS. 20 to 22A and 22B are anatomic views showing, respectively, inexploded perspective, assembled perspective, assembled lateral view, andassembled axial section view, the implantation of three implantstructures, in association with a compression stem assembly, for thefixation of the SI-Joint using a postero-lateral approach entering fromthe posterior iliac spine of the ilium, angling through the SI-Joint,and terminating in the sacral alae.

FIGS. 23 and 24A and 24B are anatomic views showing, respectively, inexploded perspective, assembled anterior view, and assembled axialsection view, the implantation of a screw-like structure for thefixation of the SI-Joint using a lateral approach laterally through theilium, the SI-Joint, and into the sacrum S1.

FIGS. 25 and 26A and 26B are anatomic views showing, respectively, inexploded perspective, assembled lateral view, and assembled axialsection view, the implantation of a screw-like structure for thefixation of the SI-Joint using a postero-lateral approach entering fromthe posterior iliac spine of the ilium, angling through the SI-Joint,and terminating in the sacral alae.

FIGS. 27 and 28A and 28B are anatomic views showing, respectively, inexploded perspective, assembled anterior view, and assembled axialsection view, the implantation of a fusion cage structure for thefixation of the SI-Joint using a lateral approach laterally through theilium, the SI-Joint, and into the sacrum S1.

FIGS. 29 and 30A and 30B are anatomic views showing, respectively, inexploded perspective, assembled lateral view, and assembled axialsection view, the implantation of a fusion cage structure for thefixation of the SI-Joint using a postero-lateral approach entering fromthe posterior iliac spine of the ilium, angling through the SI-Joint,and terminating in the sacral alae.

FIG. 31 is an exploded perspective view of the components of analternative embodiment of a compression stem assembly prior to assembly.

FIGS. 32 and 33 are perspective views of the alternative embodiment of acompression stem assembly shown in FIG. 31 after assembly, showingrotation of an anchor plate associated with the assembly from an alignedposition (FIG. 32) to a bone-gripping position (shown in FIG. 33), toanchor the assembly in bone.

FIG. 34 is a side section view of the compression stem assembly shown inFIG. 31 assembled in adjacent bone regions, which are shown in FIG. 34in a diagrammatically fashion for the purpose of illustration, withoutanatomic detail.

FIGS. 35A and 35B are side section views of an alternative embodiment ofa compression stem assembly prior to assembly (FIG. 35A) and afterassembly (FIG. 35B) in adjacent bone regions, which are shown in FIGS.35A and 35B in a diagrammatically fashion for the purpose ofillustration, without anatomic detail.

FIGS. 36A and 36B are side section views of a radially compressibleimplant prior to assembly (FIG. 36A) and after assembly (FIG. 36B) inadjacent bone regions, which are shown in FIGS. 36A and 36B in adiagrammatically fashion for the purpose of illustration, withoutanatomic detail.

DETAILED DESCRIPTION

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention that may be embodied inother specific structure. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

I. The Compression Stem Assembly

FIGS. 1 and 2 show in assembled and exploded views, respectively, arepresentative configuration of a compression stem assembly 10 sized andconfigured for the fixation of bone fractures (i.e., fixation of partsof the same bone) or for the fixation of bones which are to be fused(arthrodesed) (i.e. fixation of two or more individual bones that areadjacent and/or jointed). For the sake of shorthand, the assembly 10will sometimes be called a bone fixation/fusion compression assembly, toindicate that it can perform a fixation function between two or moreindividual bones), or a fusion function between two or more parts of thesame bone, or both functions. As used herein, “bone segments” or“adjacent bone regions” refer to either situation, i.e., a fracture linein a single bone or a space or joint between different bone segments. InFIG. 1, the bone segment or adjacent bone regions are showndiagrammatically without anatomic detail for the purpose ofillustration. Later, e.g., in FIGS. 13 to 16 and FIGS. 20 to 22, thebone segments or adjacent bone regions are shown in a specific anatomicsetting, comprising the joint between the sacrum and the ilium of thepelvis, also anatomically called the sacroiliac joint (SI-Joint).

As shown in FIGS. 1 and 2, the compression stem assembly 10 comprises ananchor body 12, which (as shown in FIG. 1) is sized and configured to beplaced in compression within bone segments or adjacent bone regions. Ina representative embodiment, the anchor body 12 takes the form of acylindrical anchor pin or rod. Still, the anchor body 12 can possessother geometries.

The anchor body 12 is anchored at a distal end to a distal anchor screw14 coupled to an interior bone region in one side of the space or joint.The anchor body 12 is secured at a proximal end, on the opposite side ofthe space or joint, to an exterior bone region by an anchor nut 16 andanchor washer 18. The distal anchor screw 14 and anchor nut 16 hold theanchor body 12 in compression and, in doing so, the anchor body 12compresses and fixates the bone segments or adjacent bone regions.

The anchor body 12 carries within the bone regions or segments anelongated, stem-like, cannulated implant structure 20. The implantstructure 20 includes an interior bore 22 that accommodates itsplacement by sliding over the anchor body 12. As FIG. 2 shows, theimplant structure 20 includes a region 24 formed along at least aportion of its length to promote bony in-growth onto or into surface ofthe structure and/or bony growth entirely through all or a portion ofthe structure. The bony-in-growth or through-growth region 24 along thesurface of the implant structure 20 accelerates bony in-growth orthrough-growth onto, into, or through the implant structure 20. Bonyin-growth or through-growth onto, into, or through the implant structure20 helps speed up the fusion process or fracture healing time of thebone segments or adjacent bone regions held in compression and fixatedby the anchor body 12.

A. The Anchor Body, Nut, and Washer

The anchor body 12, nut 16, and washer 18 can be formed—e.g., bymachining, molding, or extrusion—from a material usable in theprosthetic arts that is capable of being placed into and holdingcompressive forces and that is not subject to significant bio-absorptionor resorption by surrounding bone or tissue over time. The anchor body12, nut 16, and washer 18 are intended to remain in place for a timesufficient to stabilize the fracture or fusion site. Examples of suchmaterials include, but are not limited to, titanium, titanium alloys,tantalum, chrome cobalt, surgical steel, or any other total jointreplacement metal and/or ceramic, sintered glass, artificial bone, anyuncemented metal or ceramic surface, or a combination thereof.

In length (see FIG. 1), the anchor body 12 is sized to span a distancethrough one adjacent bone segment or region, through the interveningspace or joint, and at least partially into the other adjacent bonesegment or region. The anchor body 12 is sized on length and diameteraccording to the local anatomy. The morphology of the local structurescan be generally understood by medical professionals using textbooks ofhuman skeletal anatomy along with their knowledge of the site and itsdisease or injury. The physician is also able to ascertain thedimensions of the anchor body 12 based upon prior analysis of themorphology of the targeted bone region using, for example, plain filmx-ray, fluoroscopic x-ray, or MRI or CT scanning. A representativediameter for the anchor body 12 can range between 3.2 mm to 3.5 mm.

As best shown in FIG. 2, at least the proximal and distal regions of theanchor body 12 include external helical ridges or screw threads 26 and28 formed around the cylindrical body of the anchor body 12.Alternatively, the anchor body 12, if desired, can be threadedsubstantially along its entire length. Desirably, the direction of thescrew threads 26 and 28 is the same at both proximal and distal regionsof the anchor body 12, e.g., they desirably comprise right-hand threads.

The proximal region of the anchor body 12 carrying the threads 26 issized to extend, in use, a distance outside the one adjacent bonesegment or region. In this way, the proximal region is, in use, exposedso that the proximal anchor nut 16 and washer 18 can be attached. Theanchor nut 16 includes complementary internal screw threads that aresized and configured to mate with the external screw threads 26 on theproximal region of the anchor body 12. Representative diameters for ananchor nut 16 and anchor washer 18 for a 3.2 mm anchor body 12 are,respectively, 3.2 mm and 8 mm.

The distal region of the anchor body 12 carrying the threads 28 is sizedto extend at least partially into the other adjacent bone segment orregion, where it is to be coupled to the anchor screw 14, as will nextbe described.

B. The Anchor Screw

Like the anchor body 12, nut and washer 18, the anchor screw 14 canlikewise be formed—e.g., by machining, or molding—from a durablematerial usable in the prosthetic arts that is capable of being screwedinto bone and that is not subject to significant bio-absorption orresorption by surrounding bone or tissue over time. The anchor screw 14,like the other components of the compression assembly 10, is intended toremain in place for a time sufficient to stabilize the fracture orfusion site. Examples of such materials include, but are not limited to,titanium, titanium alloys, tantalum, chrome cobalt, surgical steel, orany other total joint replacement metal and/or ceramic, or a combinationthereof.

The anchor screw 14 is sized to span a distance within the otheradjacent bone segment or region at the terminus of the threaded distalregion 28 of the anchor body 12. As best shown in FIG. 2, the anchorscrew 14 includes external helical ridges or screw threads 30 formedaround the cylindrical body of the anchor screw 14. The external screwthreads 30 are sized and configured to gain purchase in bone whenrotated, so that the anchor screw 14 can be advanced and seated byrotation into bone in the bone segment or region. The anchor screw 14,seated within the bone, resists axial migration and separation. Arepresentative range of lengths for the anchor screw 14 can be between 5mm to 20 mm, again depending upon the demands of the local anatomy. Arepresentative diameter for the anchor screw 14 is about 7 mm.

The anchor screw 14 also includes internal helical ridges or screwthreads 32 formed within a bore in the anchor screw 14. The internalscrew threads 32 are sized and configured to mate with the complementaryexternal screw threads 28 on the distal region of the anchor body 12.When threaded and mated to the internal screw threads 32 of the anchorscrew 14, the anchor screw 14 anchors the distal region of the anchorbody 12 to bone to resists axial migration of the anchor body 12. Asbefore described, the anchor screw 14 (on the distal end) and the anchornut 16 and anchor washer 18 (on the proximal end) hold the anchor body12 in compression, thereby compressing and fixating the bone segments oradjacent bone regions.

Alternatively, in place of the anchor screw 14, an internally threadedcomponent free external screw threads can be is sized and configured tobe securely affixed within the broached bore in the most distal bonesegment where the broached bore terminates, e.g., by making aninterference fit and/or otherwise being secured by the use of adhesives.Like the anchor screw 14, the interference fit and/or adhesives anchorthe overall implant structure. Adhesives may also be used in combinationwith the anchor screw 14.

C. The Implant Structure

The implant structure 20 can be formed—e.g., by machining, molding, orextrusion—from a durable material usable in the prosthetic arts that isnot subject to significant bio-absorption or resorption by surroundingbone or tissue over time. The implant structure 20, like the othercomponents of the compression assembly 10, is intended to remain inplace for a time sufficient to stabilize the fracture or fusion site.Such materials include, but are not limited to, titanium, titaniumalloys, tantalum, tivanium (aluminum, vanadium, and titanium), chromecobalt, surgical steel, or any other total joint replacement metaland/or ceramic, sintered glass, artificial bone, any uncemented metal orceramic surface, or a combination thereof. Alternatively, the implantstructure 20 may be formed from a suitable durable biologic material ora combination of metal and biologic material, such as a biocompatiblebone-filling material. The implant structure 20 may be molded from aflowable biologic material, e.g., acrylic bone cement, that is cured,e.g., by UV light, to a non-flowable or solid material.

The implant structure 20 is sized according to the local anatomy. Themorphology of the local structures can be generally understood bymedical professionals using textbooks of human skeletal anatomy alongwith their knowledge of the site and its disease or injury. Thephysician is also able to ascertain the dimensions of the implantstructure 20 based upon prior analysis of the morphology of the targetedbone region using, for example, plain film x-ray, fluoroscopic x-ray, orMRI or CT scanning.

As FIGS. 3 to 7 show, the implant structure 20 can take various shapesand have various cross-sectional geometries. The implant structure 20can have, e.g., a generally curvilinear (i.e., round or oval)cross-section—as FIG. 3 shows for purposes of illustration—or agenerally rectilinear cross section (i.e., square or rectangular ortriangular—as FIG. 4 shows for purposes of illustration—or combinationsthereof. In FIG. 2, the implant structure 20 is shown to be triangularin cross section, which effectively resists rotation and micromotiononce implanted.

As FIGS. 5 and 6 show, the implant structure 20, whether curvilinear(FIG. 5) or rectilinear (FIG. 6) can include a tapered region 34 atleast along a portion of its axial length, meaning that the width ordiameter of the implant structure 20 incrementally increases along itsaxial length. Desirably, the tapered region 34 corresponds with, in use,the proximal region of the implant structure 20 (i.e., the last part ofthe implant structure 20 to enter bone). The amount of the incrementalincrease in width or diameter can vary. As an example, for an implantstructure 20 having a normal diameter of 7 mm, the magnitude of theincremental increase at its maximum can range between about 0.25 mm to1.25 mm. The tapered region 34 further enhances the creation andmaintenance of compression between the bone segments or regions.

To further enhance the creation and maintenance of compression betweenthe bone segments or regions (see FIG. 7), the implant structure 20,whether curvilinear or rectilinear or tapered, can include projectingbone-gripping surfaces 36 in the form of “teeth” or wings or the like.The teeth or wings 36 can project, e.g., 2 to 4 mm from the surface ofthe implant structure 20 and face in the direction of the compressionforces at proximal and distal ends of the implant structure 20, takingpurchase into the bone segments as they are compressed together by thecompression assembly.

The bony in-growth or through-growth region 24 may extend along theentire outer surface of the implant structure 20, as shown in FIG. 1 or2, or the bony in-growth or through-growth region 24 may cover just aspecified distance on either side of the bone segments or fracture line.The bony in-growth region 24 or through-growth can comprise, e.g.,through holes, and/or various surface patterns, and/or various surfacetextures, and/or pores, or combinations thereof. The configuration ofthe bony in-growth or through-growth region 24 can, of course, vary. Byway of examples, the bony in-growth or through-growth region 24 cancomprise an open mesh configuration; or beaded configuration; or atrabecular configuration; or include holes or fenestrations. Anyconfiguration conducive to bony in-growth and/or bony through-growthwill suffice.

The bony in-growth or through-growth region 24 can be coated or wrappedor surfaced treated to provide the bony in-growth or through-growthregion, or it can be formed from a material that itself inherentlypossesses a structure conducive to bony in-growth or through-growth,such as a porous mesh, hydroxyapetite, or other porous surface. The bonyin-growth or through-growth region can include holes that allow bone togrow throughout the region.

In a preferred embodiment, the bony in-growth region or through-growthregion 24 comprises a porous plasma spray coating on the implantstructure 20. This creates a biomechanically rigorous fixation/fusionsystem, designed to support reliable fixation/fusion and acute weightbearing capacity.

The bony in-growth or through-growth region 24 may further be coveredwith various other coatings such as antimicrobial, antithrombotic, andosteoinductive agents, or a combination thereof. The entire implantstructure 20 may be impregnated with such agents, if desired.

D. Implantation of the Compression Stem Assembly

FIGS. 8A to 8L diagrammatically, show for purposes of illustration, arepresentative procedure for implanting a compression stem assembly 10.More detailed, anatomically-focused descriptions of particularimplantation techniques of the compression stem assembly 10 in theSI-Joint will be described later.

The physician identifies the bone segments or adjacent bone regions thatare to be fixated or fused (arthrodesed) (see FIG. 8A). Aided byconventional visualization techniques, e.g., using X-ray imageintensifiers such as a C-arms or fluoroscopes to produce a live imagefeed which is displayed on a TV screen, a guide pin 38 is introduced byconventional means (see FIG. 8B) through the one adjacent bone segmentor region, through the intervening space or joint, and partially intothe other adjacent bone segment or region.

A cannulated drill bit 40 is passed over the guide pin 38 (see FIG. 8C),to form a pilot insertion path or bore 42 through the one adjacent bonesegment or region, through the intervening space or joint, and partiallyinto the other adjacent bone segment or region. A single drill bit ormultiple drill bits 40 can be employed to drill through bone fragmentsor bone surfaces to create a pilot bore 42 of the desired size andconfiguration. A region of bone distal to the pilot bore 42 is leftundrilled and native for seating of the anchor screw 14. When the pilotbore 42 is completed, the cannulated drill bit 40 is removed.

A broach 44 having the external geometry and dimensions matching theexternal geometry and dimensions of the implant structure 20 (which, inthe illustrated embodiment, is triangular) (see FIG. 8D) is tapped overthe guide pin 38 through the pilot bore 42. The shaped broach 44 cutsalong the edges of the pilot bore 42 to form the desired profile (which,in the illustrated embodiment, is triangular) to accommodate the implantstructure 20 through the one adjacent bone segment or region, throughthe intervening space or joint, and partially into the other adjacentbone segment or region.

The broach 44 is withdrawn (see FIG. 8E), and the anchor screw 14 (itsinternal screw threads 32 mated to the distal end of a cannulatedthreaded screw driver 46) is passed over the guide pin 38 to theterminus of the broached bore 48 in the distal bone segment. The anchorscrew 14 is threaded by operation of the screw driver 46 (see FIG. 8F)into the undrilled and native bone beyond the terminus of the broachedbore 48. For example, the anchor screw 14 can be advanced and buried inbone at least 5 mm beyond the terminus of the broached bore 48.

The threaded screw driver 46 is unthreaded by reverse rotation from theanchor screw 14, and the guide pin 38 is removed (see FIG. 8G). Theanchor body 12 is inserted, and its threaded distal end 28 is threadedinto and mated with the internal screw threads 32 of the anchor screw 14(see FIG. 8H).

As shown in FIG. 8H, due to its purposeful size and configuration, whenits threaded distal end 28 is suitably threaded to the anchor screw 14,the threaded proximal end 26 of the anchor body 12 projects an exposeddistance outside the proximal end of the broached bore 48.

The implant structure 20 is passed over the anchor body 12 by sliding itover the anchor body 12. As FIG. 8I shows, the length of the implantstructure 20 selected is less than the distance between the anchor screw14 and the threaded proximal end 26, such that, when initially insertedand before compression is applied to the anchor body 26, the distal endof the implant structure 20 is spaced from the proximal end of theanchor screw 14 (see FIG. 8I). The distance can range, e.g., betweenabout 4 mm to about 10 mm.

The anchor washer 18 is passed by sliding over the exposed threadedproximal end 26 of the anchor body 12 into abutment against an exteriorbone surface (see FIG. 8J). The anchor nut 16 is threaded onto and matedto the threaded proximal end 26 of the anchor body 12 (see FIG. 8K). Theanchor nut 16 is tightened against the anchor washer 18 using a hand (orpowered) chuck 50 (see FIG. 8L), until a desired amount of compressionis applied to the bone regions by the assembly 10. The compression willreduce the distance between the bone segments (as FIGS. 8K and 8L show),as the distal end 28 of the anchor body 12, affixed to the anchor screw14 in the more distal bone segment, draws the more distal bone segmenttoward the more proximal bone segment, while eventually placing theimplant structure 20 itself into compression within the broached bore 48as the implant structure 20 comes into abutment against both the anchorwasher 18 and the anchor screw 14, assuring intimate contact between thebony in-growth region 24 and bone within the broached bore 48.

The intimate contact created by the compression between the bonyin-growth or through-growth region 24 along the surface of the implantstructure 20 accelerates bony in-growth or through-growth onto, into, orthrough the implant structure 20, to accelerate the fusion process orfracture healing time.

As will be described in greater detail later, more than one compressionstem assembly 10 can be implanted in a given bone segment. For example,as will be described later (see, e.g., FIG. 20), three such compressionstem assemblies can be implanted to fuse a SI-Joint.

E. Alternative Embodiments 1. Distal Anchor Plate

An alternative embodiment for the compression stem assembly 10 is shownin FIGS. 31 to 33. In use, the compression stem assembly 10 is sized andconfigured to be implanted in adjoining bone segments, which areseparated by a space or joint, for the purpose of bone fixation or jointfusion, as already described.

In this embodiment (see FIG. 31), the anchor body 12, nut 16, and washer18 are sized and configured as previously described. Likewise, theimplant structure 20 is sized and configured with a generallyrectilinear cross section, as also earlier described and shown in FIG.4.

In this embodiment, instead of a threaded anchor screw 14, the distalend of the assembly 10 is anchored into bone by a generally rectilinearanchor plate 58. The anchor plate 58 is formed—e.g., by machining, ormolding—from a hard, durable material usable in the prosthetic arts thatis capable of cutting into and gaining purchase in bone, and that is notsubject to significant bio-absorption or resorption by surrounding boneor tissue over time.

As best shown in FIGS. 31 and 32, the rectilinear anchor plate 58 issized and configured to match the rectilinear cross section of theimplant structure itself. In the illustrated arrangement, the implantstructure 20 is generally triangular in cross section, and so, too, isthe anchor plate 58. As such, the anchor plate 58 includes apexes 64.The sides of the anchor plate 58 between the apexes are sharpened tocomprise bone cutting edges 72.

The anchor plate 58 also includes a bore 60 in its geometric center (seeFIG. 31). Internal helical ridges or screw threads 62 are formed withinthe bore 68. The internal screw threads 62 are sized and configured tomate with the complementary external screw threads 28 on the distalregion of the anchor body 12. The distal region of the anchor body 12can thereby be threaded to the anchor plate 58 (as shown in FIG. 32).When threaded to the anchor body 12, the anchor plate 58 rotates incommon with the anchor body 12 (as shown in FIG. 33).

Prior to introduction of the implant structure 20 into the broached bore48 formed in the manner previously described (and as shown in FIGS. 8Ato 8D), the anchor body 12 is passed through the bore 22 of the implantstructure 20, and the anchor plate 58 is threaded to the distal threadedregion 26 of the anchor body 12, which is sized to project beyond thedistal end of the implant structure 20. Further, as FIG. 32 shows, theanchor plate 58 is additionally rotationally oriented in a positionaligned with the distal end of the implant structure 20. In the alignedposition (FIG. 32), the apexes 64 of the anchor plate 58 overlay andregister with the apexes 66 of the distal end of the implant structure20. The implant structure 20, anchor body 12, and anchor plate 58 areintroduced as a unit through the broached bore 48 in the orientationshown in FIG. 32. In the aligned position, the anchor plate 58 offers noresistance to passage of the implant structure 20 through the broachedbore 48.

Upon contacting the terminus of the broached bore, the proximal end ofthe anchor body 58 is rotated 60.degree. degrees (as shown in FIG. 33).The rotation moves the anchor plate 58 into an extended, bone-grippingposition not longer aligned with the distal end of the implant structure20 (as is shown in FIG. 33). In the extended, bone-gripping position,the apexes 64 of the triangular anchor plate 58 project radially outwardfrom the triangular sides 68 of the implant structure 20. The anchorplate 58 presents at the distal end of the implant structure 20 anenlarged lateral surface area, larger than the cross sectional area ofthe implant structure itself.

During rotation of the anchor plate 58 toward the bone-grippingposition, the cutting edges 72 of the anchor plate 58 advance into boneand cut bone, seating the anchor plate 58 into bone in the bone segmentor region (see FIG. 34). In the bone-gripping position, the anchor plate58 anchors the distal end of the anchor body 12 into bone. The anchorplate 58 resists axial migration and separation, in much the samefashion as the anchor screw 14.

The sides 68 of the implant structure 20 at the distal end of thestructure 20 preferably include cut-outs 70 (see FIGS. 31 and 32). Thecut-outs 70 are sized and configured so that, when the anchor plate 58is rotated into its bone-gripping position, the body of the anchor plate58 adjoining the apexes detents and comes to rest within the cut outs70, as FIG. 33 shows. Nested within the cut-outs 70, further tighteningof the anchor nut 16 and washer 18 at the proximal end of the anchorbody 12, as previously described, locks the anchor plate 58 in thebone-gripping, anchored position. By tightening the anchor nut, the moredistal end of the anchor body 12, anchored by the plate 58 in the secondbone segment, draws the second bone segment toward the first bonesegment, reducing the space or joint between them, while eventuallycompressing the implant structure 20 between the distal anchor plate 58and the proximal nut/washer (as FIG. 34 shows), thereby comprising acompression stem assembly 10.

2. Two Piece Compressible Implant Structure

An alternative embodiment of a compressible implant structure is shownin FIGS. 35A and 35B. In use, the implant structure is sized andconfigured to be implanted in adjoining bone segments, which areseparated by a space or joint, for the purpose of bone fixation or jointfusion, as already described.

In this embodiment (see FIG. 35A), the implant structure can possess acircular or curvilinear cross section, as previously described. Unlikeprevious implant structures, the implant structure 20 shown in FIG. 35Acomprises two mating implant components 74 and 78.

As before described, each implant component 74 and can be formed—e.g.,by machining, molding, or extrusion—from a durable material usable inthe prosthetic arts that is not subject to significant bio-absorption orresorption by surrounding bone or tissue over time.

Each implant component 74 and 78 includes exterior bony in-growth orthrough-growth regions, as previously described.

Prior to introduction of the implant structure, a broached bore isformed through the bone segments in the manner previously described, andis shown in FIGS. 8A to 8D. The implant component 74 is sized andconfigured to be securely affixed within the broached bore in the mostdistal bone segment where the broached bore terminates, e.g., by makingan interference fit and/or otherwise being secured by the use ofadhesives. The implant component 74 is intended to anchor the overallimplant structure.

The implant component 74 further includes a post 76 that extends throughthe broached bore into the most proximal bone segment, where thebroached bore originates. The post 76 includes internal threads 80.

The second implant component 78 is sized and configured to be introducedinto the broached bore of the most proximal bone segment. The secondimplant component includes an interior bore, so that the implantcomponent 78 is installed by sliding it over the post 76 of the firstimplant component 74, as FIG. 35B shows.

An anchor screw 16 (desirably with a washer 18) includes external screwthreads, which are sized and configured to mate with the complementaryinternal screw threads 80 within the post 76. Tightening the anchorscrew 16 draws the first and second implant components 74 and 78together, reducing the space or joint between the first and second bonesegments and putting the resulting implant structure into compression,as FIG. 35B shows.

3. Radial Compression Split Implant Structure

An alternative embodiment of an implant structure 82 is shown in FIGS.36A and 36B. In use, the implant structure 82 is sized and configured tobe implanted in adjoining bone segments, which are separated by a spaceor joint, for the purpose of bone fixation or joint fusion, as alreadydescribed. The implant structure 82 is sized and configured to be placedinto radial compression.

The implant structure 82 includes a body that can possess a circular orcurvilinear cross section, as previously described. As before described,the implant structure 82 can be formed—e.g., by machining, molding, orextrusion—from a durable material usable in the prosthetic arts that isnot subject to significant bio-absorption or resorption by surroundingbone or tissue over time.

The implant structure 82 includes one or more exterior bony in-growth orthrough-growth regions, as previously described.

Unlike previously described implant structures, the proximal end of theimplant structure 82 includes an axial region of weakness comprising asplit 84. Further included is a self-tapping screw 16. The screw 16includes a tapered threaded body. The tapered body forms a wedge ofincreasing diameter in the direction toward the head of the screw 16.The screw 16 is self-tapping, being sized and configured to beprogressively advanced when rotated into the split 84, while creatingits own thread, as FIG. 36B shows.

Prior to introduction of the implant structure 84, a broached bore isformed through the bone segments in the manner previously described, andas shown in FIGS. 8A to 8D. The implant structure 84 is introduced intothe broached bore, as FIG. 36A shows. The implant structure is desirablysized and configured to be securely affixed within the broached bore inthe most distal bone segment where the broached bore terminates, e.g.,by making an interference fit and/or otherwise being secured by the useof adhesives. The interference fit and/or adhesives anchor the overallimplant structure 84.

After introduction of the implant structure 84 into the broached bore,the self-tapping screw 16 (desirably with a washer 18) is progressivelyadvanced by rotation into the split 84. The wedge-shape of the threadedbody of the screw 16 progressively urges the body of the implantstructure 84 to expand axially outward along the split 84, as FIG. 36Bshows. The expansion of the diameter of the body of the implantstructure 82 about the split 84 presses the proximal end of the implantstructure 82 into intimate contact against adjacent bone. The radialexpansion of the body of the implant structure 82 about the split 84radially compresses the proximal end of the implant structure 82 againstbone. The radial compression assures intimate contact between the bonyin-growth region and bone within the broached bore, as well as resistsboth rotational and axial migration of the implant structure 82 withinthe bone segments.

F. Implant Structures Without Compression

It should be appreciated that an elongated, stem-like, implant structure20 having a bony in-growth and/or through-growth region, like that shownin FIG. 2, can be sized and configured for the fixation of bonefractures (i.e., fixation of parts of the same bone) or for the fixationof bones which are to be fused (arthrodesed) throughout the body withoutassociation with a compression stem assembly 10 as just described, orwithout other means for achieving compression of the implant structureas just described. The configuration and use of representativeelongated, stem-like, implant structures 20 having bony in-growth and/orthrough-growth regions 24 for the fixation of bone fractures (i.e.,fixation of parts of the same bone) or for the fixation of bones whichare to be fused, without association with a compression stem assembly10, are described, e.g., in U.S. patent application Ser. No. 11/136,141,filed on May 24, 2005, titled “SYSTEMS AND METHODS FOR THE FIXATION ORFUSION OF BONE,” now U.S. Pat. No. 7,922,765 B2, which is incorporatedherein by reference.

II. Arthrodesis of the Sacroiliac Joint Using the Implant Structures

Elongated, stem-like implant structures 20 like that shown in FIG. 2(and the alternative embodiments) make possible the fixation of theSI-Joint (shown in anterior and posterior views, respectively, in FIGS.9 and 10) in a minimally invasive manner, with or without associationwith a compression stem assembly 10. These implant structures 20 can beeffectively implanted through the use of two alternative surgicalapproaches; namely, (i) a Lateral Approach, or (ii) a Postero-LateralApproach. Either procedure is desirably aided by conventional lateraland/or anterior-posterior (A-P) visualization techniques, e.g., usingX-ray image intensifiers such as a C-arms or fluoroscopes to produce alive image feed which is displayed on a TV screen.

A. The Lateral Approach 1. Without Association of a Compression StemAssembly

In one embodiment of a lateral approach (see FIGS. 11, 12, and 13A/B),one or more implant structures 20 are introduced (without use of acompression stem assembly 10) laterally through the ilium, the SI-Joint,and into the sacrum S1. This path and resulting placement of the implantstructures 20 are best shown in FIGS. 12 and 13A/B. In the illustratedembodiment, three implant structures 20 are placed in this manner. Alsoin the illustrated embodiment, the implant structures 20 are triangularin cross section, but it should be appreciated that implant structures20 of other cross sections as previously described can be used.

Before undertaking a lateral implantation procedure, the physicianidentifies the SI-Joint segments that are to be fixated or fused(arthrodesed) using, e.g., the Faber Test, or CT-guided injection, orX-ray/MRI of SI Joint.

Aided by lateral and anterior-posterior (A-P) c-arms, and with thepatient lying in a prone position (on their stomach), the physicianaligns the greater sciatic notches (using lateral visualization) toprovide a true lateral position. A 3 cm incision is made startingaligned with the posterior cortex of the sacral canal, followed byblood-tissue separation to the ilium. From the lateral view, the guidepin 38 (with sleeve) (e.g., a Steinmann Pin) is started resting on theilium at a position inferior to the sacrum S1 end plate and justanterior to the sacral canal. In A-P and lateral views, the guide pin 38should be parallel to the S1 end plate at a shallow angle anterior(e.g., 15.degree. to 20.degree. off horizontal, as FIG. 13A shows). In alateral view, the guide pin 38 should be posterior to the sacrumanterior wall. In the A-P view, the guide pin 38 should be superior tothe S1 inferior foramen and lateral of mid-line. This correspondsgenerally to the sequence shown diagrammatically in FIGS. 8A and 8B. Asoft tissue protector (not shown) is desirably slipped over the guidepin 38 and firmly against the ilium before removing the guide pin 38sleeve.

Over the guide pin 38 (and through the soft tissue protector), the pilotbore 42 is drilled in the manner previously described, as isdiagrammatically shown in FIG. 8C. The pilot bore 42 extends through theilium, through the SI-Joint, and into the S1. The drill bit 40 isremoved.

The shaped broach 44 is tapped into the pilot bore 42 over the guide pin38 (and through the soft tissue protector) to create a broached bore 48with the desired profile for the implant structure 20, which, in theillustrated embodiment, is triangular. This generally corresponds to thesequence shown diagrammatically in FIG. 8D. The triangular profile ofthe broached bore 48 is also shown in FIG. 11.

As shown in FIGS. 11 and 12, a triangular implant structure 20 can benow tapped (in this embodiment, without an associated compression sleeveassembly) through the soft tissue protector over the guide pin 38through the ilium, across the SI-Joint, and into the S1, until theproximal end of the implant structure 20 is flush against the lateralwall of the ilium (see also FIGS. 13A and 13B). The guide pin 38 andsoft tissue protector are withdrawn, leaving the implant structure 20residing in the broached passageway, flush with the lateral wall of theilium (see FIGS. 13A and 13B). In the illustrated embodiment, twoadditional implant structures 20 are implanted in this manner, as FIG.12 best shows.

The implant structures 20 are sized according to the local anatomy. Forthe SI-Joint, representative implant structures 20 can range in size,depending upon the local anatomy, from about 35 mm to about 55 mm inlength, and about 7 mm diameter. The morphology of the local structurescan be generally understood by medical professionals using textbooks ofhuman skeletal anatomy along with their knowledge of the site and itsdisease or injury. The physician is also able to ascertain thedimensions of the implant structure 20 based upon prior analysis of themorphology of the targeted bone using, for example, plain film x-ray,fluoroscopic x-ray, or MRI or CT scanning.

2. With Association of a Compression Stem Assembly

As shown in FIGS. 14 to 16A/B, the lateral approach also lends itself tothe introduction of one or more implant structures 20 in associationwith compression stem assemblies 10, as previously described, laterallythrough the ilium, the SI-Joint, and into the sacrum S1. This path andresulting placement of the implant structures are best shown in FIGS.16A and 16B. As in the embodiment shown in FIGS. 11 to 13A/B, threeimplant structures 20 are placed in this manner. Also, as in theembodiment shown in FIGS. 11 to 13A/B, the implant structures aretriangular in cross section, but it still should be appreciated thatimplant structures having other cross sections, as previously described,can be used. In this embodiment of the lateral approach, the implantstructure 20 is not inserted immediately following the formation of thebroached bore 48. Instead, components of the compression stem assembly10 are installed first in the broached bore 48 to receive the implantstructure 20.

More particularly, following formation of the broached bore 48, aspreviously described, the guide pin 38 is removed, while keeping thesoft tissue protector in place. The anchor screw 14 of the compressionstem assembly 10 is seated in bone in the sacrum S1 beyond the terminusof the broached bore 48, in the manner generally shown in FIGS. 8E to8G. In this arrangement, to accommodate placement of the anchor screw 14of the compression stem assembly 10, an extent of bone in the sacrum S1is left native and undrilled beyond the terminus of the pilot bore 42and broached bore 48. The anchor screw 14 is advanced and buried in thisextent of native and undrilled bone in the sacrum S1, as FIGS. 16A and16B show, to be coupled to the threaded distal end 28 of the anchor body12.

The threaded proximal end 28 of the anchor body 12 is threaded into andmated to the anchor screw 14 within the sacrum S1, as previouslydescribed and as shown in FIG. 8H, with the remainder of the anchor body12 extending proximally through the SI-Joint and ilium, to project anexposed distance outside the lateral wall of the ilium, as FIGS. 16A and16B show. The implant structure 20 is then placed by sliding it over theanchor body 12, until flush against the lateral wall of the ilium, aspreviously described and as shown in FIG. 8I. The anchor washer 18 andnut are then installed and tightened on the proximal end of the anchorbody 12, as previously described and shown in FIGS. 8J to 8L, puttingthe assembly into compression. The resulting assembly is shown in FIGS.15 and 16A/B.

As shown in FIGS. 14 and 15, three compression stem assemblies 10 can beinstalled by lateral approach across the SI-Joint. As individualcompression stem assemblies are placed into compression by tighteningthe anchor nut 16, the implant structures of neighboring compressionstem assemblies may advance to project slightly beyond the lateral wallof the ilium. If this occurs, the projecting implant structures 20 canbe gently tapped further into the ilium over their respective anchorpins 12.

B. The Postero-Lateral Approach 1. Without Association of a CompressionStem Assembly

As shown in FIGS. 17 to 19A/B, one or more implant structures can beintroduced (without use of a compression stem assembly 10) in apostero-lateral approach entering from the posterior iliac spine of theilium, angling through the SI-Joint, and terminating in the sacral alae.This path and resulting placement of the implant structures 20 are bestshown in FIGS. 18 and 19A/B. In the illustrated embodiment, threeimplant structures 20 are placed in this manner. Also in the illustratedembodiment, the implant structures 20 are triangular in cross section,but it should be appreciated that implant structures 20 of other crosssections as previously described can be used.

The postero-lateral approach involves less soft tissue disruption thatthe lateral approach, because there is less soft tissue overlying theentry point of the posterior iliac spine of the ilium. Introduction ofthe implant structure 20 from this region therefore makes possible asmaller, more mobile incision. Further, the implant structure 20 passesthrough more bone along the postero-lateral route than in a strictlylateral route, thereby involving more surface area of the SI-Joint andresulting in more fusion and better fixation of the SI-Joint. Employingthe postero-lateral approach also makes it possible to bypass all nerveroots, including the L5 nerve root.

The set-up for a postero-lateral approach is generally the same as for alateral approach. It desirably involves the identification of theSI-Joint segments that are to be fixated or fused (arthrodesed) using,e.g., the Faber Test, or CT-guided injection, or X-ray/MRI of SI Joint.It is desirable performed with the patient lying in a prone position (ontheir stomach) and is aided by lateral and anterior-posterior (A-P)c-arms. The same surgical tools are used to form the pilot bore 42 overa guide pin 38, except the path of the pilot bore 42 now starts from theposterior iliac spine of the ilium, angles through the SI-Joint, andterminates in the sacral alae. The pilot bore 42 is shaped into thedesired profile using a broach, as before described (shown in FIG. 17),and the implant structure 20 is inserted into the broached bore 48 themanner shown in FIGS. 18 and 19A/B. The triangular implant structure 20is tapped (in this embodiment, without an associated compression sleeveassembly 10) through the soft tissue protector over the guide pin 38from the posterior iliac spine of the ilium, angling through theSI-Joint, and terminating in the sacral alae, until the proximal end ofthe implant structure 20 is flush against the posterior iliac spine ofthe ilium, as FIG. 18 shows. As shown in FIGS. 17 to 19A/B, threeimplant structures 20 are introduced in this manner. Because of theanatomic morphology of the bone along the postero-lateral route, it maybe advisable to introduce implant structures of difference sizes, withthe most superior being the longest in length, and the others beingsmaller in length.

2. With Association of a Compression Stem Assembly

As shown in FIGS. 20 to 22A/B, the postero-lateral approach also lendsitself to the introduction of one or more implant structures 20 inassociation with compression stem assemblies 10, as previouslydescribed, entering from the posterior iliac spine of the ilium, anglingthrough the SI-Joint, and advancing into the sacral alae. This path andresulting placement of the implant structures 20 with compression stemassemblies 10 are best shown in FIGS. 22A/B. As in the embodiment shownin FIGS. 17 to 19A/B, three implant structures 20 are placed inthis-manner. Also, as in the embodiment shown in FIGS. 17 to 19A/B, theimplant structures 20 are triangular in cross section, but it stillshould be appreciated that implant structures 20 of other cross sectionsas previously described can be used. In this embodiment of theposterior-lateral approach, the implant structure 20 is not insertedimmediately following the formation of the broached bore 48. Instead,components of the compression stem assembly 10 are installed in thebroached bore 48 first to receive the implant structure 20, as have beenpreviously described as is shown in FIG. 20.

As before explained, the set-up for a postero-lateral approach isgenerally the same as for a lateral approach. It is desirable performedwith the patient lying in a prone position (on their stomach) and isaided by lateral and anterior-posterior (A-P) c-arms. The same surgicaltools are used to form the pilot bore 42 over a guide pin 38 that startsfrom the posterior iliac spine of the ilium, angles through theSI-Joint, and terminates in the sacral alae. The pilot bore 42 is shapedinto the desired profile using a broach 44, as before described (and asshown in FIG. 20). In this arrangement, to accommodate placement of theanchor screw 14 of the compression stem assembly 10, an extent of bonein the sacral alae is left native and undrilled beyond the terminus ofthe formed pilot bore 42 and broached bore 48. The anchor screw 14 isadvanced and buried in this extent of native and undrilled bone in thesacral alae, as FIGS. 22A/B show, to be coupled to the threaded distalend 28 of the anchor body 12. Due to the morphology of the sacral alae,the anchor screw 14 may be shorter than it would be if buried in thesacrum S1 by the lateral approach.

The threaded proximal end 28 of the anchor body 12 is threaded into andmated to the anchor screw 14 within the sacral alae, as previouslydescribed and as shown in FIG. 8H, with the remainder of the anchor body12 extending proximally through the SI-Joint to project an exposeddistance outside the superior iliac spine of the ilium, as FIGS. 21 to22A/B show. The implant structure 20 is then placed by sliding it overthe anchor body 12, until flush against the superior iliac spine of theilium, as previously described and as shown in FIG. 8I. The anchorwasher 18 and nut are then installed and tightened on the proximal endof the anchor body 12, as previously described and shown in FIGS. 8J to8L, putting the assembly 10 into compression. The resulting assembly 10is shown in FIGS. 21 and 22A/B.

As shown in FIGS. 20 and 21, three compression stem assemblies 10 can beinstalled by postero-lateral approach across the SI-Joint. As beforeexplained, as individual compression stem assemblies 10 are placed intocompression by tightening the anchor nut 16, the implant structures 20of neighboring compression stem assemblies 10 may advance to projectslightly beyond the superior iliac spine of the ilium. If this occurs,the projecting implant structures 20 can be gently tapped further intothe superior iliac spine of the ilium over their respective anchorbodies 12.

C. Conclusion

Using either a posterior approach or a postero-lateral approach, one ormore implant structures 20 can be individually inserted in a minimallyinvasive fashion, with or without association of compression stemassemblies 10, or combinations thereof, across the SI-Joint, as has beendescribed. Conventional tissue access tools, obturators, cannulas,and/or drills can be used for this purpose. No joint preparation,removal of cartilage, or scraping are required before formation of theinsertion path or insertion of the implant structures 20, so a minimallyinvasive insertion path sized approximately at or about the maximumouter diameter of the implant structures 20 need be formed.

The implant structures 20, with or without association of compressionstem assemblies 10, obviate the need for autologous bone graft material,additional pedicle screws and/or rods, hollow modular anchorage screws,cannulated compression screws, threaded cages within the joint, orfracture fixation screws.

In a representative procedure, one to six, or perhaps eight, implantstructures 20 might be needed, depending on the size of the patient andthe size of the implant structures 20. After installation, the patientwould be advised to prevent loading of the SI-Joint while fusion occurs.This could be a six to twelve week period or more, depending on thehealth of the patient and his or her adherence to post-op protocol.

The implant structures 20 make possible surgical techniques that areless invasive than traditional open surgery with no extensive softtissue stripping. The lateral approach and the postero-lateral approachto the SI-Joint provide straightforward surgical approaches thatcomplement the minimally invasive surgical techniques. The profile anddesign of the implant structures 20 minimize rotation and micromotion.Rigid implant structures 20 made from titanium provide immediate post-opSI Joint stability. A bony in-growth region 24 comprising a porousplasma spray coating with irregular surface supports stable bonefixation/fusion. The implant structures 20 and surgical approaches makepossible the placement of larger fusion surface areas designed tomaximize post-surgical weight bearing capacity and provide abiomechanically rigorous implant designed specifically to stabilize theheavily loaded SI-Joint.

III. Arthrodesis of the Sacroiliac Joint Using Other Structures

The Lateral Approach and the Postero-Lateral Approach to the SI-Joint,aided by conventional lateral and/or anterior-posterior (A-P)visualization techniques, make possible the fixation of the SI-Joint ina minimally invasive manner using other forms of fixation/fusionstructures. Either approach makes possible minimal incision size, withminimal soft tissue stripping, minimal tendon irritation, less pain,reduced risk of infection and complications, and minimal blood loss.

For example (see FIGS. 23 and 24A/B, one or more screw-like structures52, e.g., a hollow modular anchorage screw, or a cannulated compressionscrew, or a fracture fixation screw, can be introduced using the lateralapproach described herein, being placed laterally through the ilium, theSI-Joint, and into the sacrum S1. This path and resulting placement ofthe screw-like structures 52 are shown in FIGS. 23 and 24A/B. Desirably,the screw-like structure carry a bony in-growth material or a bonythrough-growth configuration, as described, as well as being sized andconfigured to resist rotation after implantation.

Likewise, one or more of the screw-like structures 52 can be introducedusing the postero-lateral approach described herein, entering from theposterior iliac spine of the ilium, angling through the SI-Joint, andterminating in the sacral alae. This path and resulting placement of thescrew-like structure are shown in FIGS. 25 and 26A/B. Desirably, thescrew-like structures 52 carry a bony in-growth material or a bonythrough-growth configuration, as described, as well as being sized andconfigured to resist rotation after implantation, as before described.

As another example, one or more fusion cage structures 54 containingbone graft material can be introduced using the lateral approachdescribed herein, being placed laterally through the ilium, theSI-Joint, and into the sacrum S1. This path and resulting placement ofthe fusion cage structures 54 are shown in FIGS. 27 and 28A/B. Such astructure 54 may include an anchor screw component 56, to be seated inthe sacrum S1, as shown in FIGS. 27 and 28A/B.

Likewise, one or more of the fusion cage structures 54 can be introducedusing the postero-lateral approach described herein, entering from theposterior iliac spine of the ilium, angling through the SI-Joint, andterminating in the sacral alae. This path and resulting placement of thefusion cage structures 54 are shown in FIGS. 29 and 30A/B. Such astructure 54 may include an anchor screw component 56, to be seated inthe sacral alae, as shown in FIGS. 27 and 28A/B.

IV. Conclusion

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

What is claimed is:
 1. A method for the fixation or fusion of thesacroiliac joint, the method comprising: creating an insertion paththrough the ileum, across the sacroiliac joint, and into the sacrum;shaping the insertion path with a broach having a triangular crosssection inserting a compressive implant having a longitudinal axisthrough the insertion path into the ileum, through the sacroiliac joint,and into the sacrum, the compressive implant comprising an anchor bodyhaving a distal end with an external screw thread and an elongatedimplant structure configured to be coaxially disposed over a proximalportion of the anchor body; anchoring the distal end of the anchor bodyin an interior region of the sacrum before compressing the sacroiliacjoint; advancing the elongated implant structure coaxially over theproximal portion of the anchor body; abutting a washer against anexterior surface of the ileum, the washer disposed coaxially over aproximal portion of the compressive implant; and compressing thesacroiliac joint.
 2. The method of claim 1, wherein the insertion pathand the implant structure have generally concentric triangular crosssections.
 3. A method for the fixation or fusion of the sacroiliacjoint, the method comprising: inserting a guide pin through the ileum,across the sacroiliac joint, and into the sacrum under fluoroscopicguidance; passing a cannulated drill bit over the guide pin; drilling abore along the guide pin to create an insertion path through the ileum,across the sacroiliac joint, and into the sacrum; inserting acompressive implant having a longitudinal axis through the insertionpath into the ileum, through the sacroiliac joint, and into the sacrum,the compressive implant comprising an anchor body having a distal endwith an external screw thread and an elongated implant structureconfigured to be coaxially disposed over a proximal portion of theanchor body; anchoring the distal end of the anchor body in an interiorregion of the sacrum before compressing the sacroiliac joint; advancingthe elongated implant structure coaxially over the proximal portion ofthe anchor body; abutting a washer against an exterior surface of theileum, the washer disposed coaxially over a proximal portion of thecompressive implant; and compressing the sacroiliac joint.
 4. The methodof claim 3, wherein the insertion path and the elongated implantstructure have generally concentric curvilinear cross sections.
 5. Themethod of claim 3, further comprising shaping the bore with a broachhaving a rectilinear cross section.
 6. The method of claim 5, whereinthe insertion path and the elongated implant structure have generallyconcentric rectilinear cross sections.
 7. The method of claim 3, furthercomprising shaping the bore with a broach having a triangular crosssection.
 8. The method of claim 7, wherein the insertion path and theimplant structure have generally concentric triangular cross sections.9. The method of claim 3, wherein the step of compressing the sacroiliacjoint further comprises tightening a nut against the washer.